Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. The Senior Project Engineer provides project engineering for the Melville site with an emphasis on capital projects. The Junior Automation Engineer will assist with site-wide automation, developing, maintaining, and troubleshooting industrial control systems for formulation, filling, and packaging processes. This role supports major projects, ensuring they meet company standards, stay on time and budget, and provides leadership during execution with both site employees and contractors. **Main Responsibilities:** + Technical Expertise: Become proficient with site instrumentation and control systems, staying updated with current automation technology and company standards. + Design & Installation: Support the design and installation of instrumentation and control systems, ensuring compliance with company standards and regulatory expectations. + Continuous Improvement: Analyze process control to proactively address and remediate system weaknesses, enhancing reliability and robustness. + Project Management: Assist in managing capex and opex projects, working with vendors and consultants to ensure technical specifications are met. + Safety Commitment: Ensure personnel and process safety during operations and troubleshooting. + Collaboration: Collaborate with cross-functional teams, including process engineers, validation specialists, and maintenance teams. + Programming: Configure and program Supervisory Control and Data Acquisition (SCADA), Programmable Logic Controllers (PLC), and Human-Machine Interface (HMI) systems. + System Performance: Monitor and analyze process performance to identify areas for improvement. + Documentation: Assist in documenting automation processes, procedures and specifications. + Support: Provide troubleshooting support for automation-related issues. Provide 24x7 support and lead troubleshooting efforts. + Compliance: Ensure all automation systems comply with regulatory requirements, including cGMP (current Good Manufacturing Practice) standards, GAMP guidelines, and 21 CFR Part 11. + Validation: Assist computer system validation with validation activities, including writing and executing validation protocols. + Quality: Provide technical assistance to site quality systems through investigations, control system assessments, and corrective/preventative support to ensure a compliant GMP workplace. **Background and Experience:** + Bachelor’s degree in computer science, Engineering, or a related field. + Basic understanding of PLC programming and SCADA development. + Basic understanding of process instrumentation. + Familiarity with automation tools and frameworks. Rockwell Allen-Bradley a plus. + Strong problem-solving skills and attention to detail. + Excellent communication and teamwork abilities. + Willingness to learn and adapt to new technologies and methodologies. + Familiarity with system qualification (FAT/SAT, commissioning, IQ/OQ validation). + Knowledge of GxP and NIH guidelines for biological/pharmaceutical processing. + Understanding of relevant European and US regulatory requirements, including GAMP guidelines and 21 CFR Part 11. **Additional Skills:** + Self-starter with the ability to work independently in complex situations. + Leadership skills to generate options, resolve problems, and prioritize solutions. + Strong communication and interpersonal skills to interact with all organizational levels. + Strong business understanding and team player mindset. + Attention to detail, accuracy, and a quality-first mindset. + High integrity while managing multiple priorities. + Excellent computer and networking skills. + Strong troubleshooting and root cause analysis capabilities. _Kedrion Biopharma offers a number of benefits to qualifying employees, including:_ _- Medical, vision and dental insurance_ _- Life and AD&D insurance_ _- Paid holidays_ _- PTO accrual_ _- and much more!_ _Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!_ **Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.** **Salary Range: $60k - $75k** **_Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications._** _All qualified applicants will receive consideration for employment without regard_ _to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status._